Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Detailed Action
Claims 1-11 are currently pending.
Specification
The disclosure is objected to because although the additional agents listed in the method of Claim 11 are found in the original claim set of the instant application and have support in the provisional application cited above, such agents like CXCR4 inhibitors or fusion inhibitors for example, are not found in the specification. All of the agents listed in the claims must be expressly described in the specification.
Said agents are found in the claims of the earliest disclosure and are thus supported. Therefore, Claim 11 has the 11/5/2018 filing date, but the specification must be amended to include ALL the limitations of the claim set. Applicant is reminded that no new matter may be introduced by amendment in the specification or claim set, only that which has been previously disclosed.
Appropriate correction is required.
Claim Objections
Claims 1 and 3-5 depict stereoisomers with unclear orientations. The hydrogens in
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appear to be attached to the ring system with wedge bonds rather than dashed bonds.
Claims 1-5 recite “a compound or salt” and “salts thereof”. One of the salt limitations should be deleted.
Claim 6 should recite “the compound” instead of “a compound”
Claims 7-8 should recite “the composition” instead of “a composition”.
Appropriate correction is required.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
102(a)(2): The applied references in both this 102 section and the 103 section below have a common assignee, applicant, and/or joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 5 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Patent No. 11505543 (‘543; claiming domestic benefit to four US provisional applications, the earliest of which is 62655881 dated 4/11/2018, the latest being 62750336 dated 10/25/2018).
‘543 teaches
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, the second compound of instant Claim 5 in Col. 187.
Claims 3-4 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Patent No. 10954252 (‘252; claiming domestic benefit to three provisional US applications, the earliest of which is 62500005 dated 5/02/2017, the latest being 62651345 dated 4/02/2018).
‘252 teaches the following compounds:
The first compound of instant Claim 3 is taught exactly in Col 627:
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.
The second compound of instant Claim 4 (Page 5, Row 1, Col 2) is taught in Col 590, Row 3.
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.
Claim 5 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by US PGPub No. 20210393633 (‘633; claiming domestic benefit to one provisional US application: 62750395 filed 10/25/2018).
‘633 teaches
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, the second compound of instant Claim 5
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, in Para 167.
Claim 5 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by US PGPub No. 20210395262 (‘262; claiming domestic benefit to one provisional US application: 62749801 filed 10/24/2018).
‘262 teaches
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, the second compound of instant Claim 5
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, in Para 137.
Claim 5 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Patent No. 11541055 (‘055; claiming domestic benefit to one provisional US application: 62749818 filed 10/24/2018).
‘055 teaches
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, the second compound of instant Claim 5
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, in Col 102.
Claim 5 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by US PGPub 20210403465 (‘465; claiming domestic benefit to one provisional US application: 62751733 filed 10/29/2018).
‘055 teaches
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, the second compound of instant Claim 5
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, in Para 116.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10954252 (‘252; claiming domestic benefit to three provisional US applications, the earliest of which is 62500005 dated 5/02/2017, the latest being 62651345 dated 4/02/2028) .
‘252 teaches a genus of HIV inhibitors in Formula I, several exemplary compounds, compositions thereof, and methods of treatment therewith (Abstract). Claims 6-11 of ‘252 teach compositions comprising excipients and the claimed routes of administration and co-therapeutics.
The ‘252 compounds of Claim 5 apply to the compounds of instant Claims 1-5 as follows:
The last compound of instant Claim 1 varies from the ‘252 compound in Col 578, Row 3 by a Me/H exchange on the topmost oxygen:
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Although, ‘252 Formula I does not teach H can be used in place of Me at the same position atop the oxygen, it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09. H differs from Me (CH2-H) by a CH2. Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to exchange the Me with an H.
The first compound of instant Claim 2 differs from ‘252 compound Col 618, Row 2 by a F/H exchange:
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Formula I of ‘252 teaches H and F are alternative embodiments (Col 554, G16, Lines 50-53).
The first compound of instant Claim 3 is taught by ‘252 exactly Col 627, Row 2:
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The second compound of instant Claim 4 is taught as the ‘252 compound of Col 590, Row 3.
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The first compound of instant Claim 5 differs from ‘252 compound Col 578, Row 3 by a OMe/Br exchange:
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Formula I of ‘252 teaches Br and O-C1 alkyl are alternative embodiments (Col 554, G14, Lines 37-43).
The modifications taught above are either suggested in ‘252 or characterized as known, routine modifications by the MPEP. Because the modifications are suggested to yield compounds of similar properties, one of skill in the art before the effective filing date of the instant claims would find it obvious to form and reasonably expect the successful formation of HIV inhibitors.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
NONPROVISIONAL:
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-10 of U.S. Patent No. 10954252 (hereinafter referred to as ViiV).
The claimed invention is rendered obvious over ViiV as the claimed invention teaches several HIV inhibitors, compositions, and methods of use thereof whereas ViiV teaches a genus of HIV inhibitors in Formula I, several exemplary compounds, compositions thereof, and methods of treatment therewith. Claims 8-11 of ViiV teach routes of administration and co-therapeutics.
The ViiV compounds of Claim 5 anticipate or render obvious the compounds of instant Claims 1-5.
The last compound of instant Claim 1 varies from ViiV compound Col 578, Row 3 by a Me/H exchange on the topmost oxygen:
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Although, ViiV Formula I does not teach H can be used in place of Me at the same position atop the oxygen, it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09. H differs from Me (CH2-H) by a CH2. Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to exchange the Me with an H.
The first compound of instant Claim 2 differs from ViiV compound Col 618, Row 2 by a F/H exchange:
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Formula I of ViiV teaches H and F are alternative embodiments (Col 554, G16, Lines 50-53).
The first compound of instant Claim 3 is taught by ViiV exactly Col 627, Row 2:
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The second compound of instant Claim 4 is taught as the ViiV compound of Col 590, Row 3.
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The first compound of instant Claim 5 differs from a ViiV compound Col 578, Row 3 by a OMe/Br exchange:
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Formula I of ViiV teaches Br and O-C1 alkyl are alternative embodiments (Col 554, G14, Lines 37-43).
Since both applications teach the same or similar compounds used to treat HIV, compositions thereof, and methods of treatment therewith, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of ViiV.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
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